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EP0212599A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Multizone analytical element for immunoassays having detectable signal concentrating zone

Assignee: Bayer Corp
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Filing: 1986-08-18
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Granted: —
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Expires: 2006-08-18
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Abstract

Abstract A multizone test device for the determination of analyte from a liquid test medium upon contact with the liquid test medium and a labeled reagent comprising a chemical group having a detectable chemical property. The test device preferably comprises multilayers including a reagent layer incorporated with an immobilized reagent and a detection layer incorporated with an immobilized form of an interactive detection reagent for the labeled reagent. The immobilized reagent in the reagent layer and the labeled reagent comprise specific binding partners which will bind to each other dependent upon the amount of analyte present. Labeled reagent which does not become bound to the immobilized reagent in the reagent layer migrates into the detection layer and interacts with the immobilized interactive detection reagent therein which results in the localized generation of a detectable reaction product which preferably is also immobilized in the detection zone. As a result, reverse migration of the labeled reagent, and preferably the detectable reaction product from the detection layer is prevented and the detectable chemical property provided by the label of the labeled reagent is localized in the detection layer for the precise measurement thereof and correlation to the amount of analyte in the test medium.

Inventors

  • 👤 Alfred C. Greenquist

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-29 18:41
CPC Classifications
G; G01; G01N; G01N33/00; G01N33/48; G01N33/50; G01N33/53; G01N33/543; G01N33/54366; G01N33/54386; G01N33/54387; G01N33/54391; G01N33/52; G01N33/525; G01N33/536; G01N33/542; Y; Y10; Y10S; Y10S435/00; Y10S435/805; Y10S435/968; Y10S436/00; Y10S436/807; Y10S436/81; Y10S436/815

Claims Analysis

Total Claims: 11
Claim 1
Independent Claim 154 words
A multizone test device for the specific binding assay determination of an analyte in a liquid test medium involving binding between (i) the analyte and a labeled or immobilized form of the analyte or of a binding analog thereof, and (ii) an immobilized or labeled form, respectively, of a binding partner of the analyte, the labeled one of the analyte, analog thereof, or binding partner being a labeled reagent comprising a detectable chemical group which interacts with a detectant composition to produce a detectable signal, characterized in that the test device comprises, in fluid flow contact, (1) a reagent zone comprising a solid, porous matrix incorporated with the immobilized one of the analyte, analog thereof, or binding partner, and (2) a detection zone comprising a solid, porous matrix for receiving and measuring labeled reagent which migrates into such zone and incorporated with an immobilized form of at least one component of the detectant composition.
Claim 2
Dependent Claim 154 words
A multizone test device for the specific binding assay determination of an analyte in a liquid test medium involving binding between (i) the analyte and a labeled or immobilized form of the analyte or of a binding analog thereof, and (ii) an immobilized or labeled form, respectively, of a binding partner of the analyte, the labeled one of the analyte, analog thereof, or binding partner being a labeled reagent comprising a detectable chemical group which interacts with a detectant composition to produce a detectable signal, characterized in that the test device comprises, in fluid flow contact, (1) a reagent zone comprising a solid, porous matrix incorporated with the immobilized one of the analyte, analog thereof, or binding partner, and (2) a detection zone comprising a solid, porous matrix for receiving and measuring labeled reagent which migrates into such zone and incorporated with an immobilized form of at least one component of the detectant composition.
Claim 3
Dependent Claim 70 words
The test device of Claim 1 wherein the detectant component immobilized in the detection zone participates in a chemical reaction with the labeled reagent to produce a product which provides the detectable signal and wherein the detectable chemical group in the labeled reagent is an enzymatically active group, preferably (i) an enzyme or (ii) a substrate or cofactor for such enzyme, wherein the immobilized detectant component is the other thereof.
Claim 4
Dependent Claim 36 words
The test device of any of Claims 1 and 2 wherein the detectable chemical group in the labeled reagent is an enzyme and wherein the immobilized detectant component is a chromogenic, fluorogenic, or chemiluminescent substrate therefor.
Claim 5
Dependent Claim 52 words
The test device of any of Claims 1 to 3 wherein the detectable chemical group in the labeled reagent is a polymer residue to which are attached internally-qhenched multiple fluorescers and wherein the immobilized detectant component is an enzyme which acts on the fluorescer-polymer residue to cleave and release unquenched fluorescer molecules.
Claim 6
Dependent Claim 33 words
The test device of any of Claims 1 to 4 wherein the immobilized detectant component undergoes a chemical reaction with the labeled reagent to form an immobilized product which provides the detectable signal.
Claim 7
Dependent Claim 35 words
The test device of any of Claims 1 to 5 wherein the detectable product is insoluble or the detectable product is soluble and the detection zone additionally comprises an immobilizing agent for such soluble product.
Claim 8
Dependent Claim 48 words
The test device of any of Claims 1 to 6 wherein the detectable chemical group in the labeled reagent comprises a fluorescer, preferably a polymer residue bearing multiple fluorescers, and wherein the detectant component immobilized in the detectionzone is a quencher for the fluorescence of the labeled reagent.
Claim 9
Dependent Claim 44 words
The test device of any of Claims 1 tc 7 wherein the detectant component is immobilized in the detection zone by being covalently coupled to the matrix comprised therein or by being attached to a high molecular weight polymeric substance dispersed in said matrix.
Claim 10
Dependent Claim 24 words
The test device of any of Claims 1 to 8 wherein the binding partner of the anlyte is an antibody or a fragment thereof.
Claim 11
Dependent Claim 68 words
The test device of any of Claims 1 to 9 wherein the reagent and detection zones are in the form of layers in fluid flow contact and which test device additionally comprises a reagent layer comprising a solid, porous matrix incorporated with a test medium soluble form of the labeled reagent and a support element situated on the opposite side of the detection layer from the reagent layer.

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